1. Osteoporosis consult Session
Dr. David Hanley Osteoporosis Centre (Calgary)
Osteoporosis consult Session

2. *no conflicts of interest to declare
Introduction of staff, and housekeeping items (b/r’s, water, parking, agenda, timeframe).
Include statement about pre-req of on-line OP & Bone health education/AHL class/In house Monday RRDTC class.
*no conflicts of interest to declare

4. Osteoporosis: Normal aging or disease?
Everyone loses bone mass as they age
Loss of bone mass has no symptoms and if you never fracture, perhaps it doesn’t matter!
“Fragility fractures” do happen with increasing frequency as you age and lose bone

5. The goal of an “osteoporosis” assessment
NOT to see if you are losing bone or going to lose bone
NOT to see if you have “osteoporosis” according to an x-ray (BMD)
NOT necessarily to prevent age-associated bone loss

6. The real goal:
Knowing that we will all age and lose bone in the process:
What is the chance that you will actually have a “fragility fracture” in the next 10 years?
What kind of interventions are available to reduce the risk of such fractures
IS IT WORTH IT FOR ME?
NOBODY HAS to take drugs to prevent fracture – it is 100% your decision

7. Why are we only talking about the next 10 years?
Our ability to predict fracture risk depends upon long term studies of patients
There are no studies that span years
The drugs that we have to reduce fracture risk have not been studied for more than 10 year time periods
Ultimately impossible to predict the good or bad that will happen in 30 years

8. Hip Fractures
Commonly occur from a fall or an impact to the side of the hip causing a break in the upper thigh (femur) bone
Pain will occur over the outer upper thigh or the groin region with significant discomfort; a shortening in leg length may also be noted
Surgical intervention includes stabilization of the fracture with hardware (screws, nails, or plates) to “fix” the bone in-place
Others may require surgical replacement of some or all of their hip components (hemiarthroplasty or total hip replacement)

9. Spinal Compression (Vertebral) Fractures
These are small breaks that occur in the bones (vertebrae) of your back
Small breaks can continue to form until the bone (vertebrae) collapses
2/3 of individuals with compression fractures do not feel any pain
Fractures can change the strength and shape of your back, and lead to a loss in your height
Pain medication, decreased activity, bracing, and in some rare cases surgery may be required as treatment

10. Potential Complications from Fractures
Pain
Immobility/Decreased activity level
Loss of independence
Depression
Surgical complications (infections, bed sores, pneumonia, blood clots, nutritional wasting)
Neurological complications (neuropathy) including weakness, tingling, and numbness may be associated with spinal fractures
Extreme cases can result in death

11. STEP 1: Evaluate your major risk factors

12. STEP 2: Look at your Bone Density
Note: this is optional! Fracture risk prediction tools are still pretty good even if you don’t have an up to date BMD
There are many other equally important factors that go into the program for predicting fracture risk

13. How to read a BMD
BMD simply tells you how your bone density compares to what is the AVERAGE of a young person of your sex
The report talks about “T-scores” which is just a mathematical way of expressing the results.
A negative T-score means “below the average”
The bigger the number, the farther away from the average you are

14. Remember, bone loss is natural
Most menopausal women or older men will have T scores less than -1.5

15. RECORD YOUR BONE DENSITY T-SCORES ON YOUR SHEET NOW
Handout ipads now

16. STEP 3: Predicting the future!

32. My risk of fracture in the next 10 years?

33. What is a “good deal” when it comes to deciding what’s best?
How excited are you to hear about:
40% off of a $2.00 item?
40% off a $ item?
$2.00 x 0.6 = $1.20
$ x 0.6 = $

34. Is it worth doing something about my fracture risk?
16%
9.6%
4.5%
2.7%

35. OPTIONS
Remember how you feel about the OVERALL benefit of any drug therapy so far
Hearing about the drug options may increase or decrease your interest in being treated

36. Options for Good Bone Health
A reminder from your Osteoporosis Bone & Health class regarding Nutrition and Exercise:
Maintain a well balanced food diet in accordance with Canada’s Food Guide that is rich in dietary calcium
Participate in regular physical activity
Further questions or inquiries can be discussed with the Osteoporosis clinic’s registered dietitian (RD) and registered nurse (RN) – please refer to their contact sheet

37. Osteoporosis consult Session
Osteoporosis drug treatments
Osteoporosis consult Session

38. Objectives What medications are available?
How do the medications work?
What are the
potential side effects?
cost & insurance coverage?
length of therapy?
administration?

39. Basic medication approach to fracture risk reduction
DRUGS that preserve the bone you have (and make it harder over time)
The DRUG that builds bone

40. Drugs that PRESERVE your bone...
Raloxifene, Bisphosphonates, Denosumab

41. Raloxifene (Evista®) For post-menopausal women, not for men
Has estrogen-like effects on bones
May slightly reduce the risk of breast cancer
Does not cause return of menstrual bleeding
Daily tablets, with or without food

42. Raloxifene (Evista®) Cost <$30 per month
Covered by Senior’s Blue Cross if meeting criteria:
≥20% fracture risk and intolerant to
weekly Alendronate or Risedronate

43. Raloxifene (Evista®)
Possible side effects: hot flashes (7-10%), leg cramps, blood clot in the veins (estimated risk 1 in 1000 users over 3 years)
If you are going to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking Raloxifene at least 3 days before, to reduce your risk of blood clots in the veins.
No scheduled stop date, this medication may be used long term

44. Bisphosphonates Oral Alendronate - Fosamax® weekly,
Risedronate - Actonel® weekly, monthly
Intravenous
Zoledronic acid - Aclasta® yearly

45. Oral bisphosphonates
Cost: once-weekly bisphosphonates are approx. $20 per month
Covered by Senior’s Blue Cross
It’s important to take it correctly for proper absorption

46. How to take oral bisphosphonates
Take on empty stomach in the morning, with one full glass of water
Stay in an upright position for at least 30 minutes
Wait 1 hour (at least ½ hour) before food or other medications
Wait at least 2 hours before taking minerals (calcium, iron, magnesium)

47. Intravenous bisphosphonates
Zoledronic Acid – Aclasta®
Once a year, given intravenously over 15 mins
Cost: <$400 per dose
Covered by private insurance, under special authorization by Senior’s Blue Cross (most patients do not qualify)

48. Intravenous bisphosphonates
Infusions are coordinated by infusion programs (cost included with price of drug)
Your family physician will be provided with information on enrolment

49. Side effects of bisphosphonates
Oral: indigestion, heartburn, nausea (around 10%)
IV: flu-like symptoms (10%)
Both: osteonecrosis of the jaw, atypical fractures of the thigh bone

50. Osteonecrosis of the jaw (ONJ)
Osteonecrosis = death of bone
An area of exposed bone in the upper or lower jaw that does not heal within 8 weeks
May or may not be painful

51. ONJ Exact cause is unknown
Most cases occurred in patients with past or ongoing treatment with intravenous bisphosphonates, in high doses for treatment of cancer
In addition to bisphosphonates therapy, these patients took other medications and have undergone tooth extraction or dental implants

52. ONJ Estimated risk is 1 in 10 000 to 1 in 100 000 in patients
Risk is higher in cancer patients using high dose IV bisphosphonates

53. What can I do to prevent ONJ?
Avoid smoking, limit alcohol
Inform your dentist if you are taking a bisphosphonate
Routine dental check-ups
If possible, have invasive dental procedures done prior to starting bisphosphonates
Dental cleaning, fillings or root canals do not increase the risk of ONJ

54. Atypical femoral fractures (AFF)
Most commonly occurs in the upper thigh bone (femur), away from the hip
Can occur without trauma or a fall
May affect both thigh bones

55. AFF
Vast majority of such fractures, when due to bisphosphonate therapy, occur during long term therapy (more than 5-7 years)
With long term continuous usage, atypical fractures may affect 1 in 1000 or less
The majority of the benefits from the drugs are achieved in the first 5 years of therapy

56. AFF The optimal duration of bisphosphonate treatment is not known
Warning sign: dull or aching pain in the groin or thigh weeks or months before the fracture

57. Risk of bisphosphonate side effects vs. other rare events
Figure 1. Risk of major osteoporotic fracture and other rare events. (Brown et al., 2014)

58. Duration of therapy
Most of the benefits in fracture risk reduction achieved in the first 5 years of treatment
Concern about rare but possible side effects with longer term use
Controversy:
Many OP specialists recommend stopping drug after 5 years for a “drug holiday” of 3 to 5 years
Some OP specialists may choose to continue drug therapy up to 10 years in special cases/highest risk

59. Denosumab
Denosumab - Prolia®
Subcutaneous injection every 6 months
Cost: $ per injection
Covered by private insurance, under special authorization by Senior’s Blue Cross (most patients do not qualify)
Injections can be done by family physicians, registered nurses or community pharmacists

60. Denosumab
Possible side effects: pain in arms, legs, or back; dry skin, skin infection (rare), osteonecrosis of the jaw (rare), atypical fractures of the thigh bone (rare)
Very similar to bisphosphonates in terms of clinical effects
Optimal duration of therapy not yet known, more studies and clinical experience will be needed.

61. The Drug that builds new bone...

62. Parathyroid Hormone Therapy
Teriparatide - Forteo®
Parathyroid hormone stimulates osteoblasts cells to build new bone
Daily self-injection (like insulin) for 24 months
Cost: $1100 per pen (28 doses)
Not covered by Senior’s Blue Cross, covered by private insurance

63. Teriparatide Financial assistance program available in select cases
Use is limited to 2 years (maximal response usually seen within first 12 months)
Osteosarcoma (seen in older rat studies) did not occur in humans
Possible side effects: leg cramps, dizziness, nausea

64. Teriparatide
If you choose to start Teriparatide, you are encouraged to contact us at the Osteoporosis Centre
Injection teaching will be provided by Forteo Customer Care (FCC) program

65. Your medication options…
Raloxifene
Alendronate, Risedronate (Oral Bisphosphonates)
Zoledronic acid (IV bisphosophonate)
Denosumab
Teriparatide
(show demo pen)

66. What is the BEST drug? The scientific answer: NOBODY KNOWS
Each drug proven effective at reducing risk of fracture in it’s own right
The choice basically comes down to patient preference considering:
Cost (and insurance)
Potential side effect profile
Personal preference based on knowledge of drug
The OP doctors rarely choose for you!
(show demo pen)

67. Current osteoporosis medications:
On average, the anti-fracture drug treatments can significantly lower the risk of fracture by about 40%
In comparison, taking calcium and vitamin D may not significantly lower the risk of fracture in the majority of adults

68. QUESTIONS
After that, decisions!